UDI device identifier

THERA Plus 64431942B

UDI device identifier 00049696186797 · FOURSTAR GROUP INC.

Key facts

Primary DI 00049696186797
Brand name THERA Plus
Version or model 64431942B
Company FOURSTAR GROUP INC.
DUNS number 656091279
Product code QRL
GMDN term Manual blood lancing device, reusable
Premarket submission K222472
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Oct 27, 2023
Version date Nov 6, 2023
Description Lancing Device 1CT

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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